Method for opening and closing surgical wounds

ABSTRACT

A surgical method and apparatus for opening and closing surgical wound utilizes an elastic member which is adhered across the patient&#39;s skin at the treatment site. The wound is opened by cutting through the elastic member and through the patient&#39;s skin to permit a surgical procedure to be conducted. The wound is then closed by reapproximating the patient&#39;s skin at the treatment site and by bringing the cut edges of the elastic member together and adhering a relatively inelastic sealing member over the elastic member to maintain the cut edges while the wound heals.

BACKGROUND OF THE INVENTION

The present invention relates to surgical methods and apparatus, and inparticular relates to methods and apparatus designed to open and closesurgical wounds without using sutures, staples or other devicesextending into the patient's body.

A variety of suture materials have been used in the past for closingsurgical wounds. In recent times, staples have been utilized as asubstitute for sutures. There have also been suggestions for usingstraps, buttons, zippers and glues to achieve these same ends.

It is now known that a surgical wound closure technique that extends aforeign substance into the patient's body (as sutures, staples, etc.)creates a higher likelihood of introduction of undesirable bacteria intothe patient's body, thus increasing the incidence of infection.

There have been techniques which have been described for avoiding theuse of devices which extend into the patient's body. For example, theuse of Steri-Strips has been suggested to approximate the edges of theskin at the wound site, without the use of skin sutures, clips orstaples, with lower infection rate being experienced. See SurgicalPractice News, May 1988, p. 21. See also U.S. Pat. No. 4,038,989 toRomero-Sierra et al.

It is also preferable to avoid the use of sutures, staples and the likefor purposes of reducing the amount of scar tissue forming at thesurgical wound. There have been suggestions in the prior art forutilizing non-invasive materials for that purpose; see, for example,U.S. Pat. No. 3,847,155 to Bernaola, which teaches the use of aco-polymer film applied to the skin and over the wound.

Other techniques which have been suggested for avoiding the necessity ofutilizing intrusive materials include surgical dressings which areattached on opposite sides of the wound, and which are in turn joinedtogether by sutures, zippers or similar fasteners. See, for example,U.S. Pat. No. 2,752,921 to Fink.

SUMMARY OF THE INVENTION

The present invention is directed to a method which is designed toassist in both opening and closing a surgical wound at the treatmentsite for purposes of reducing the potential for infection and the amountof scar tissue present in the wound following healing, as well as toachieve other benefits described in greater detail below.

In general terms, the method of the present invention contemplates theuse of an elastic member which is adhered across the patient's skin atthe treatment site. The surgical wound is then opened by cutting throughthe elastic member and the patient's skin at the site, and conducting asurgical procedure in the wound. Thereafter the patient's skin isreapproximated at the treatment site by bringing the cut edges of theelastic member together and adhering a sealing member to the elasticmember to maintain the cut edges of the elastic member together whilethe surgical wound heals.

It is preferred, although not required, that both the elastic member andthe sealing member be formed of transparent materials so as to permitobservation of the treatment site before the wound is opened and afterthe wound is closed.

The elastic member preferably comprises an elongated sheet of an elasticmaterial which has an elastic adhesive along one surface, is relativelyimpervious to blood and body fluids, and has an elastic memory.Suitably, the elastic sheet has a dimension longer than the surgicalwound, so as to leave uncut the ends of the elastic sheet. The sealingmember preferably comprises a sheet dimensioned to fit on the exposedsurface of the elastic sheet. Further, the sealing sheet is relativelyinelastic with respect to the elastic sheet and has an adhesive alongone surface thereof for adhering to the exposed surface of the elasticsheet across both the uncut and cut portions of the elastic sheet.

The specific materials selected for use with the elastic and sealingsheets, as well as the applied adhesives, form an important part of thisinvention. As noted above, the elastic sheet has an elastic memory andis relatively impervious to blood and body fluids. To this end, theelastic sheet is selected so as to have a non-tear and elastic memorycharacteristic capable of withstanding stretching to about twice itsoriginal dimensions. This permits the elastic sheet to be subjected tosignificant retraction along with the patient's skin, so as to open thesurgical wound and permit the surgery to be conducted. Afterwards, theelastic memory is utilized to reapproximate the original position of theedges of the cut skin, even when the wound has been left open for asubstantial period of time (for example, under septic conditions in thewound where the wound must be left open and closed at a later date). Thesealing sheet preferably comprises a semi-rigid polyurethane or similarmaterial which will not stretch appreciably following application to theexposed surface of the elastic sheet.

The adhesive applied to the bottom of the elastic sheet is specificallyselected to preferably provide the following characteristics: a highmoisture-vapor barrier for the elastic sheet; a high degree ofelasticity, so as to expand and retract with the elastic sheet duringthe surgical procedure; and a high degree of adhesive "aggressiveness",for a few days following surgery. The adhesive applied to the bottom ofthe sealing sheet is selected to have a substantially greateraggressiveness than the elastic sheet adhesive, and is preferablyinitially removable (as, for example, pressure sensitive) if the sealingsheet needs repositioning.

Other features are available with the method and apparatus utilized inthe present invention. For example, when a closed-cell foam is used forthe elastic sheet, the closed-cell foam may be impregnated with anantiseptic material or other medicine to promote wound treatment.Another feature contemplated is the utilization of a cannula extendingthrough the sealing and elastic sheets, for administering localanesthetics or other medicines adjacent the wound.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross section, partially broken away, illustrating theapparatus of the present invention.

FIG. 2 is a top plan view illustrating the sealing member portion of theapparatus shown in FIG. 1.

FIG. 3 is a bottom plan view of the elastic member portion of theapparatus shown in FIG. 1.

FIGS. 4, 5 and 6 progressively illustrate steps in the method, as wellas the apparatus utilized with the invention.

FIG. 7 is a cross-sectional elevation of the apparatus of the presentinvention.

FIG. 8 is a cross-sectional elevation, partially broken away,illustrating an alternative form of the present invention.

FIG. 9 is a cross-sectional elevation, partially broken away,illustrating an alternative form of the present invention including amedicine administrating feature.

FIGS. 10 and 11 are top plan views illustrating an alternative use forthe apparatus of the present invention when the edges of the surgicalwound are to be formed in elliptical pattern.

FIG. 12 is a top plan view of an alternate embodiment of the sealingsheet illustrated in FIG. 2.

DETAILED DESCRIPTION OF THE INVENTION

A detailed description of the preferred embodiments of the presentinvention will now be described with reference to the drawing.

A first embodiment of the apparatus is shown in FIGS. 1, 2 and 3. Theapparatus is provided with an elastic member 10, comprising an elasticsheet 12 which, in this example, is a closed-cell, polyvinyl chloridefoam having a cell diameter of not greater than about 1/32 of an inch,and preferably on the order of 1/64 of an inch. A suitable foam ismanufactured by Uniroyal under the trademark Ensolite. The foam sheet 12is treated with a vinyl-nitrile extender to impart high elasticity andelastic memory characteristics. The foam sheet 12 is substantiallyimpervious and non-absorptive to blood and other body fluids emittedfrom a surgical wound, and has a sufficient non-tear and elastic memorycharacteristic to be capable of withstanding stretching to about twicethe original dimensions of the sheet 12.

As discussed in greater detail below with reference to FIG. 7, anelastic silicone sheet 40 may be substituted for the elastic foam sheet12 in FIG. 1 when translucency is an important requirement for theparticular surgical procedure being undertaken. However, when the PVCfoam sheet 12 is utilized, it preferably has a thin polyurethane film 14across its upper surface. The top of the upper polyurethane film definesan exposed surface 15, to which a sealing sheet 20 may be attached.

As is illustrated in FIGS. 1 and 3, the bottom of the elastic sheet 10is provided with an adhesive layer 18. The adhesive layer 18 ispreferably selected to provide the following characteristics: a highdegree of elasticity in order to expand and contract with the elasticsheet 12; a low vapor-fluid transmission rate, that is, beingsubstantially impervious to blood and other body fluids from thesurgical wound; and being sufficiently aggressive to adhere to apatient's skin during stretching of the elastic sheet 12, and for aperiod of days thereafter. A specific adhesive which is suitable forthis purpose is manufactured by Adhesives Reasearch, Inc., and isidentified by the mark ARclad DEV-7125; this adhesive is highly elasticand has a peel strength of about 2,000 grams in a 90 degree peel test.Other equivalent adhesives are suitable as well. When the elastic sheetis formed of transparent silicone, as described above, then atransparent adhesive is necessary. A suitable silicone adhesive for thispurpose is manufactured by Dow Corning as adhesive number 355, which hasa peel strength on the order of 1,600 grams in a 90 degree peel test.

Referring now to FIGS. 1 and 3, the apparatus of the present inventionis also provided with a sealing member 20. The sealing member 20comprises a sealing sheet 22 which is relatively inelastic with respectto the elastic sheet 12, and which has a highly aggressive adhesivelayer 24 across its bottom surface in order to adhere to the upper,exposed surface 15 of the elastic member 10. A suitable material for thesealing sheet 22 is a semi-rigid polyurethane approximately 0.050 inchesthick, and having a durometer rating of about 85 on the durometer "A"scale.

The sealing member 20 is provided with holes 26 extending completelytherethrough, to permit blood and other body fluids to drain withoutcreating pockets between the elastic and sealing members 10 and 20,respectively. As shown in FIG. 2, each hole 26 laterally overlaps thenext adjacent hole, with plural rows of holes being provided to insureproper drainage from a wound irrespective of where the wound is locatedunder the sealing member 20.

The particular adhesive selected for the layer 24 is chosen to provide ahigh degree of adhesive agressiveness (and being preferably moreaggressive than the adhesive layer 18). It is also preferred that thesealing member 20 be initially removable, to permit the physician tofirst position the sealing member 20 over the elastic member 10, and ifthe sealing member 20 is improperly positioned or if the skin at thewound site is improperly reapproximated, then the sealing member 20 maybe removed from the elastic member 10 and the procedure reinitiated.This may be achieved with an adhesive at layer 24 which is pressuresensitive. Preferably, this adhesive has a peel strength on the order of3,000 grams in a 90 degree peel test.

The term "aggressive" as applied to an adhesive generally, andspecifically to the adhesive layers 18 and 24, refers to the adhesive'sshear, peel and tack characteristics. Shear is defined as the amount ofstress before the adhesive disassociates from itself; peel refers to theadhesion longevity; and tack refers to the initial grip characteristicsof the adhesive.

A description of the manner in which the apparatus shown in FIGS. 1-3 isutilized to facilitate the opening and closing of a surgical wound willnow be described with reference to FIGS. 4-6.

Noting FIG. 4, a patient 30 is prepared for surgery at a treatment site31 on the patient's body. Initially, the surgeon selects an elasticmember 10 having dimensions suitable for the particular surgicalprocedure to be undertaken, and then adheres the adhesive layer 18 tothe treatment site 31. The surgeon then forms a cut 19 completelythrough the elastic member 10 and through the patient's skin 34 to forma surgical wound 32 (FIG. 5). In selecting the elastic member 10 andmaking the incision, the surgeon leaves uncut the end areas 13 and 17.

Thereafter, the skin 34 at the treatment site 31 is retracted byretractor arms 36 and 38 so as to create a greater opening for thesurgical procedure in the wound 32. As is shown in the top view of FIG.5, the retractors 36 and 38 substantially stretch both the skin and theelastic sheet 12, which are stretched together.

Under certain septic conditions, it may be necessary to leave thesurgical wound 32 open for a substantial period of time prior toclosing. Such situations occur in the case of gunshot wounds, rupturedappendix, a perforated colon diverticulum or ulcer, or similarconditions in which the wound is rendered potentially infected. Theelastic sheet 12 and the adhesive 18 are specifically selected to beretractable with the patient's skin 34 under those conditions for asubstantial period of time, and to have a sufficient elastic memory toreturn with the skin to the approximate position of the skin beforesurgery, when wound closure is undertaken with the elastic member 10, asdescribed next.

FIG. 6 illustrates the manner in which the edges of the wound arereapproximated, and the wound is closed. As there shown, the cut 19 inthe elastic member 10 is reapproximated to the original position, withthe underlying cut edges of the skin 34 also being reapproximated,because of the close adherence between the member 10 and the skin 34.The surgeon then applies the sealing member 20 over the exposed surface15 of the elastic member 10, bridging both the cut 19 and the uncutareas 13 and 17. As was noted previously, the adhesive layer 24 ispreferably initially removable, so that the sealing member 20 may befirst lightly fixed to the upper surface 15 of the elastic member 10. Itwill be appreciated that the surgical staff achieves reapproximation ofthe cut 19 and the skin 34 by pushing the skin and the elastic member 10together at the treatment site 31; after application of the sealingmember 20 (but before pressure is applied to firmly seal the adhesivelayer 24) the skin at the treatment site 31 may be released, todetermine if proper reapproximation of the wound has been achieved. Ifnot, the releasable characteristics of the adhesive layer 24 will permitinitial removal of the sealing member 20, without substantialdifficulty. Thereafter, the cut 19 and the skin 34 may bereapproximated, and the procedure continued until the desiredpositioning is achieved. The sealing member 20 may then be firmlyadhered to the upper surface 15 of the elastic member 10.

As noted above, the adhesive layer 18 is selected so that it retains itsadhering characteristics for a period of time following surgerysufficient to permit healing. After an adequate period, the elasticmember 10 may then be peeled away from the patient's skin.

An alternative form of the elastic member for the apparatus of thepresent invention will now be described with reference to FIG. 7, inwhich the elastic member 40 comprises a transparent silicone sheethaving substantially the same elasticity, non-tear and elastic memorycharacteristics as the sheet 12 illustrated in FIG. 1 and describedabove. The elastic sheet 40 has a transparent adhesive layer 42 acrossits bottom surface. In this embodiment, both the elastic sheet 40 andthe sealing sheet 22, (as well as the respective adhesive layers 42 and24) are transparent, in order to permit observation of the treatmentsite before the wound is opened, and of the wound after closure.

FIG. 7 also illustrates how the cut 49 and the wound 32 appears in crosssection; it will be noted that the holes 26 in the sealing sheet 22provide a path for the flow of blood and other body fluids from thewound 32 and through the cut 49 (and likewise the cut 19 shown in FIGS.4-6), and thus avoids a degradation of the adhesive layers 18, 42 and24, and further avoids substantial intrusion of those fluids into theclosed-cell PVC foam sheet 12 illustrated in FIG. 1 above, or betweenthe elastic and sealing sheets.

FIG. 8 illustrates an alternative form of the apparatus of the presentinvention, in which the elastic sheet 50 (like the sheet 12 in FIG. 1,or the sheet 40 in FIG. 7), has an adhesive 52 across its bottomsurface. In this embodiment, the sealing member 60 comprises arelatively inelastic sheet having overlapping sides 68 dimensioned tofit closely over the longitudinal edges the elastic sheet 50. As shownin FIG. 8, the sealing member 60 likewise includes an adhesive layer 64,which is intended to adhere the sheets 50 and 60 together.

FIG. 9 illustrates an additional feature which may be utilized with theapparatus of the present invention. A cannula 70 is extended through thesealing and elastic members 20 and 10, and into the treatment siteadjacent the wound. The cannula 70 includes an injection port 76,through which a needle 78 may extend to administer local anesthetics orother medicines.

FIGS. 10 and 11 illustrate the manner in which the apparatus of thepresent invention may be utilized for certain types of surgical woundswhere the edges of the wound are not parallel, such as a wound where asubstantial portion of the patient's tissue (as, for example a radicalmastectomy) is to be removed.

Noting FIG. 10, the tissue portion to be removed is designated by thereference numeral 80. Two strips 86 and 90 are provided, each of whichis comprised of materials like the elastic member 10 in FIG. 1 (oralternatively the sheet 40 in FIG. 7), and each of which has an adhesivelike the adhesive layer 18 across the bottom surface and in contact withthe patient's skin. The strips 86 and 90 are disposed on the patient'sskin and around the area of tissue 80 to be removed, with a peripheraledge of each strip 86, 90 overlapping and parallel with the line wherean adjacent surgical incision is to be made, as defined by dotted lines82 and 84 in FIG. 10. Each strip 86, 90 has opposing ends 87, 88 and 91,92 respectively. The surgeon conducts the surgical procedure forremoving the tissue 80 by cutting along the lines 82 and 84 and throughthe strips 86 and 90, thereby defining the edges of the surgical wound.To close the wound, the two strips 86, 90 are brought together (noteFIG. 11). A sealing member 20 is then placed over the top surface of theelastic strips 86, 90 so as to retain the cut edges of the wound and theperipheral edges of the two closure strips 86, 90 while the wound heals.

An alternative form of the sealing member 20 of FIGS. 1 and 2 is shownin FIG. 12. In this embodiment, the sealing member, referred to byreference numeral 21 in FIG. 12, has oblong slits 27 in place of theholes 26 shown in FIG. 2. The slits 27 achieve the same objective as theholes 26, by insuring that a series of drainage openings are locatedover the wound, even when the wound is not underneath the centerline ofthe sealing member 21.

It will be appreciated by those skilled in the art that the apparatusand method described allow the opening and closing of surgical wounds ina facile manner, without the use of sutures, staples or the like so asto achieve the objectives discussed above.

What is claimed is:
 1. A method for opening and closing a surgical woundat a treatment site, comprising the steps of:adhering an elastic memberacross the skin at the treatment site; providing the elastic member witha dimension longer than the surgical wound so as to leave the elasticmember uncut on opposite ends of the surgical wound; opening thesurgical wound by cutting through the elastic member and through thepatient's skin at the treatment site; conducting a surgical procedure inthe wound; reapproximating the patient's skin at the treatment site bybringing the cut edges of the elastic member together; and thereafteradhering a flat, relatively inelastic sealing member over the elasticmember for maintaining the cut edges of the elastic member togetherwhile the surgical wound heals.
 2. The method recited in claim 1 whereinthe elastic member is transparent, so as to permit observation of thetreatment site before the wound is opened.
 3. The method recited inclaim 2 wherein the sealing member is transparent, to permit observationof the treatment site after the wound is closed.
 4. The method recitedin claim 1 wherein the sealing member is adhered across the elasticmember and does not extend into the patient's body.
 5. The methodrecited in claim 1 wherein the elastic member is substantiallynon-absorptive to blood and body fluids from the surgical wound.
 6. Themethod recited in claim 1 wherein the elastic member has an elasticmemory, so as to facilitate the step of reapproximating the patient'sskin after retraction of the skin at the treatment site.
 7. The methodrecited in claim 1 wherein the adhering step comprises the steps ofcoating the elastic member with an elastic adhesive and applying theadhesive to the treatment site.
 8. The method recited in claim 7 whereinthe elastic adhesive provides a moisture-vapor barrier for the elasticmember.
 9. The method recited in claim 8 wherein the elastic adhesivehas an adhesive characteristic for at least a few days following thesurgical procedure.
 10. The method recited in claim 9 further comprisingthe step of adhering the sealing member to the elastic member with anadhesive which has a greater adhesive characteristic than the elasticmember adhesive.
 11. The method recited in claim 10 further comprisingthe step of utilizing a sealing member adhesive which is initiallyreleasable.
 12. The method recited in claim 1 wherein the elastic membercomprises a closed cell foam having a cell size not greater than about1/32 of an inch in diameter.
 13. The method recited in claim 1 furthercomprising the step of utilizing an elastic member having a non-tear andelastic memory characteristic capable of withstanding stretching toabout twice the original dimensions of the elastic member.
 14. A methodfor opening and closing a surgical wound at a treatment site, comprisingthe steps of:adhering an elastic member across the skin at the treatmentsite; opening the surgical wound by cutting through the elastic memberand through the patient's skin at the treatment site; conductingsurgical procedure in the wound; reapproximating the patient's skin atthe treatment site by bringing the cut edges of the elastic membertogether; adhering a sealing member over the elastic member formaintaining the cut edges of the elastic member together while thesurgical wound heals; and providing the elastic member with a dimensionlonger than the surgical wound so as to leave the elastic member uncuton opposite ends of the surgical wound, and wherein the sealing memberis adhered to the cut and uncut portions of the elastic member.
 15. Amethod for opening and closing a surgical wound at a treatment site,comprising the steps of:adhering an elastic member across the skin atthe treatment site; providing the elastic member with a dimension longerthan the surgical wound so as to leave the elastic member uncut onopposite ends of the surgical wound; opening the surgical wound bycutting through the elastic member and through the patient's skin at thetreatment site; conducting a surgical procedure in the wound;reapproximating the patient's skin at the treatment site by bringing thecut edges of the elastic member together; adhering a sealing member overthe elastic member for maintaining the cut edges of the elastic membertogether while the surgical wound heals; and draining blood and bodyfluids from the surgical wound through the sealing member.
 16. A methodfor opening and closing a surgical wound at a treatment site, comprisingthe steps of:adhering an elastic member across the skin at the treatmentsite; opening the surgical wound by cutting through only a portion ofthe elastic member and through the patient's skin at the treatment site;conducting a surgical procedure in the wound; reapproximating thepatient's skin at the treatment site by bringing the cut edges of theelastic member together; adhering a sealing member over the cut anduncut portion of said elastic member for maintaining the cut edges ofthe elastic member together while the surgical wound heals;administering a local anesthetic or other medicine into the treatmentsite adjacent the wound through the sealing and elastic members, andafter wound closure; and extending a cannula through the sealing andelastic members for facilitating the medicine administration step.
 17. Amethod for opening and closing a surgical wound at a treatment site,comprising the steps of:attaching an elastic member across the patient'sskin at the treatment site, the elastic member having an elastic memory,being substantially non-absorptive to blood and body fluids and havingan outer surface receptive to an adhesive; opening the surgical wound bycutting through only a portion of the elastic member and through thepatient's skin; conducting a surgical procedure in the wound includingretracting the skin and the elastic member; closing the wound bybringing the cut edges of the elastic member together; providing asealing member formed of a relatively inelastic plastic sheet having anadhesive along one side for adhering to the outer surface of the elasticmember; adhering the sealing member across the cut and uncut portions ofthe elastic member; and thereafter maintaining the wound closed forhealing with only the sealing member.
 18. The method recited in claim 17wherein both the elastic member and the sealing member are transparent.19. The method recited in claim 17 wherein the elastic member is aclosed cell foam.
 20. The method recited in claim 17 further comprisingthe steps of:leaving the wound open for a substantial period of timewhen the potential for infection exists in the wound or similarconditions are experienced; and thereafter utilizing the elastic memoryof the elastic member to reapproximate the original position of theedges of the cut skin at the treatment site.
 21. The method recited inclaim 20 further comprising the step of utilizing an elastic memberhaving a non-tear and elastic memory characteristic capable ofwithstanding stretching and expansion to about twice the originaldimensions of the elastic member.